Transdermal therapeutic system for the transdermal administration of guanfacine comprising a silicone polymer

1. A transdermal therapeutic system for the transdermal administration of guanfacine comprising a guanfacine-containing layer structure, said guanfacine-containing layer structure comprising:

A) a backing layer; and

B) a guanfacine-containing layer;

wherein the guanfacine-containing layer comprises a first silicone polymer in an amount of from 50 to 70% by weight based on the total weight of the guanfacine containing layer, and a second silicone polymer in an amount of from 15 to 45% by weight based on the total weight of the guanfacine-containing layer.

2. The transdermal therapeutic system according to claim 1 , wherein the guanfacine-containing layer is a guanfacine-containing matrix layer comprising:

i) guanfacine; and

ii) the first silicone polymer and the second silicone polymer.

3. The transdermal therapeutic system according to claim 1 , wherein the guanfacine-containing layer structure is self-adhesive.

4. The transdermal therapeutic system according to claim 1 , wherein the guanfacine-containing layer structure comprises the guanfacine in the form of the free base dispersed in the guanfacine-containing layer, and wherein the guanfacine-containing layer structure comprises guanfacine in an amount of from 1 to 75 mg/TTS.

5. The transdermal therapeutic system according to claim 1 , wherein the guanfacine-containing layer comprises guanfacine in an amount of from 1 to 20%, based on the total weight of the guanfacine-containing layer.

6. The transdermal therapeutic system according to claim 1 , wherein the first silicone polymer and the second silicone polymer are is obtainable by polycondensation of silanol endblocked polydimethylsiloxane with a silicate resin.

7. The transdermal therapeutic system according to claim 1 , wherein the guanfacine-containing layer further comprises at least one additive selected from the group consisting of dispersing agents, permeation enhancers, and solubilizers.

8. The transdermal therapeutic system according to claim 7 , wherein the dispersing agent is selected from the group consisting of esters of fatty acids with polyols, fatty alcohols, polyethylene glycols having a number average molecular weight of from 300 to 400, and polyethylene glycol alkyl ethers.

9. The transdermal therapeutic system according to claim 7 , wherein the permeation enhancer is selected from the group consisting of diethylene glycol monoethyl ether (transcutol), oleic acid, levulinic acid, caprylic/capric triglycerides, diisopropyl adipate, isopropyl myristate, isopropyl palmitate, lauryl lactate, triacetin, dimethylpropylene urea, and oleyl alcohol.

10. The transdermal therapeutic system according to claim 7 , wherein the solubilizer is selected from the group consisting of copolymers derived from esters of acrylic and methacrylic acid, polyvinylpyrrolidone, vinylpyrrolidone-vinyl acetate copolymers, and polyvinyl caprolactam-polyvinyl acetate-polyethylene glycol graft copolymers.

11. The transdermal therapeutic system according to claim 7 , wherein the at least one additive in present an amount of from 0.5 to 10% by weight or from 1 to 10% by weight, based on the total weight of the guanfacine-containing layer.

12. The transdermal therapeutic system according to claim 1 , wherein the guanfacine-containing layer has (i) an area weight ranging from 40 to 250 g/m 2 , (ii) an area of release ranging from 1 to 100 cm 2 , or both (i) and (ii).

13. A method of treating hypertension or attention deficit hyperactivity disorder (ADHD) in a human patient, the method comprising administering the transdermal therapeutic system according to claim 1 to the skin of the human patient in need thereof.

14. The method according to claim 13 , wherein the transdermal therapeutic system is applied to the skin of the human patient for at least 24 hours.

15. The method according to claim 14 , wherein the transdermal therapeutic system is applied to the skin of the human patient for at least 72 hours.

16. The method according to claim 14 , wherein the transdermal therapeutic system is applied to the skin of the human patient for about 84 hours.

17. The method according to claim 13 , wherein the human patient is at the age of from about 6 to 17.

18. The method according to claim 13 , wherein the transdermal therapeutic system is provided as an adjunctive therapy to stimulant medications in the human patient.